Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure (NCT06817447) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure
168 participantsStarted 2025-03-01
Plain-language summary
This study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI ablation alone.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Aged 18 to 80 years
* Typical AFL referring for ablation
* No prior history of AF
* Fulfilling the criteria for HF: New York Heart Association (NYHA) function class II or greater; and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) \>125 pg/ml in sinus rhythm or \>365 pg/ml in AFL
* Optimized guideline-directed medical therapy for HF for at least one month
* A minimum of anticoagulation for three weeks
* Sign informed consent
Exclusion Criteria:
* Any AF episodes documented during 48-hour Holter monitoring
* Presence of left atrial thrombus
* HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
* Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment
* Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
* Untreated hypothyroidism or hyperthyroidism
* Dialysis-dependent terminal renal failure
* Life expectancy \<12 months due to non-cardiovascular causes.
* Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
* Female under pregnancy or breast-feeding
* Involved in other studies
What they're measuring
1
Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death
Timeframe: From randomization until completion of the planned follow-up, assessed up to 48 months
Trial details
NCT IDNCT06817447
SponsorThe First Affiliated Hospital with Nanjing Medical University